Status:
COMPLETED
The TESLA Trial: Thrombectomy for Emergent Salvage of Large Anterior Circulation Ischemic Stroke
Lead Sponsor:
Mercy Health Ohio
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The primary objective of the trial is to establish the effectiveness of IAT (versus medical management) in patients with moderate-large infarcts (NCCT ASPECTS 2-5) at baseline, with adaptive enrichmen...
Detailed Description
Prospective, randomized, open-label, blinded endpoint study. Patients presenting with symptoms of AIS who have evidence of a moderate-large infarct volume (Non-contrast CT Alberta Stroke Program Early...
Eligibility Criteria
Inclusion
- 18 to 85 years of age
- Presenting with symptoms consistent with an acute ischemic stroke
- Imaging evidence of an anterior circulation occlusion of the Internal Carotid Artery (ICA) terminus and/or Middle Cerebral Artery Main Stem (MCA M1) segment
- NIHSS score \>6 at the time of randomization
- Ability to randomize within 24 hours of stroke onset
- Pre-stroke mRS score 0-1
- Ability to obtain signed informed consent
- Imaging evidence of moderate-large infarct defined as:
- 1\. NCCT ASPECTS 2-5
Exclusion
- Females who are pregnant, or those of child-bearing potential with positive urine or serum beta Human Chorionic Gonadotropin (HCG) test
- Known severe allergy (more than a rash) to contrast media uncontrolled by medications
- Refractory hypertension (defined as persistent systolic blood pressure \>185 mmHg or diastolic blood pressure \>110 mmHg)
- CT evidence of the following conditions:
- Midline shift or herniation
- Evidence of intracranial hemorrhage
- Mass effect with effacement of the ventricles
- Computed Tomography Angiography (CTA) evidence suggestive of difficult endovascular access per the treating interventionalist
- Presence of cervical ICA occlusion (e.g., related to atherosclerotic disease or dissection)
- Rapidly improving neurological status prior to randomization to NIHSS \<6
- Bilateral strokes or multiple intracranial occlusions
- Intracranial tumors
- Known hemorrhagic diathesis, coagulation factor deficiency, or on anticoagulant therapy with an International Normalized Ratio (INR) of \>3.0 or Partial Thromboplastin Time (PTT) \>3 times of normal
- Baseline platelet count \<30,000 per microliter (µl)
- Life expectancy less than 90 days prior to stroke onset
- Participation in another randomized clinical trial that could confound the evaluation of the study
- Any other condition (in the opinion of the site investigator) that precludes an endovascular procedure or poses a significant hazard to the patient if an endovascular procedure was performed
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 18 2023
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03805308
Start Date
July 16 2019
End Date
November 18 2023
Last Update
April 23 2024
Active Locations (43)
Enter a location and click search to find clinical trials sorted by distance.
1
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States, 72205
2
PIH Health Good Samaritan Hospital and PIH Health Whittier Hospital
Los Angeles, California, United States, 90017
3
Pomona Valley Hospital Medical Center
Pomona, California, United States, 91767
4
Sutter Institute for Medical Research
Sacramento, California, United States, 95816